List of required documents registration of medical devices

Досье для регистрации ИМН

List of required documents for conduction of confirmation procedure to technical regulations in Ukraine

 

LIST OF REQUIRED DOCUMENTS FOR CONDUCTION OF CONFIRMATION PROCEDURE TO TECHNICAL REGULATIONS

1. Application filled in by applicant of authorized person;

2. Power of Attorney to represent interest of applicant in Ukraine;

3. CE Certificate (assessment of conformity to requirements of the directive);

4. QMS Certificates (ISO 13485);

5. QMS documents:
- Policy in quality sphere,
- Goals in quality sphere,
- organizational chart of the enterprise,
- quality guide,
- documented procedures (methods): management of documents, management of records, analysis by management of enterprise, internal audits, discrepancies management, corrective and preventive actions, organization and control of production, withdrawal from the market of non-conforming products;

6. Technical file for products ( with analysis of risks, description of composition of the product, used raw materials, control methods);

7. The list of standards by which the products are manufactured or other ND (normative documents: pharmacopeia and others);

8. Materials on clinical trials from the manufacturer;

9. Test reports of product in the laboratory, with ISO 17025 competence and recognized by ILAC to meet:
- The technical requirements;
- Biological tests;
- Electromagnetic compatibility (the equipment);
- Bacteriological studies (if there is this requirement for medical devices). Protocols have to be provided with the documents certifying the competence of the laboratory;

10. Quality certificates (certificate of quality), which are issued by the manufacturer, the test reports in the laboratory of the manufacturer (if any);

11. Declaration of Conformity;

12. Instruction on use;

13. Labelling project.